Position description:

The finance manager will support corporate consolidations and work across the Business Partnering organization with the primary focus being to streamline workflow while increasing visibility into revenue, cost and cash flow performance. This role will be responsible for assessing current reporting practices and identifying areas for improvement in order to efficiently meet organization needs.   This will include implementing system enhancements, developing standard and custom reporting templates and actively collaborating with other Finance team members and functional leaders in developing and consolidating the annual operating plan and quarterly forecasts.

In addition, this role will play a key role in the preparation of Board of Directors, Audit Committee and senior management reporting. 

Responsibilities:

• Administer and maintain all aspects of SAP BPC, including data management, allocations and member hierarchies
• Provide support on system issues that arise and long term enhancement requests
• Act as the primary liaison with the IT department on upgrades and enhancement requests that fall outside of the scope and capability or the Finance department
• Actively collaborate with other Finance members to asses, develop & implement internal and external reporting needs and facilitate the creation of reports to meet these needs, including standard templates as well as custom ad hoc reports
• Support the consolidation of the annual operating plan and quarterly forecasts, including the creation of presentation templates for senior management and board of directors
• Coordinate and collaborate with other finance team members in the preparation of Board of Directors, Audit Committee and monthly senior management reporting
• Lead/support continuous improvement initiatives and sharing of best practices across the organization
• Perform ad hoc analysis on various business aspects as required 

Requirements:

• Bachelors or equivalent degree with concentration in a financial discipline or Information Technology required; MBA preferred
• A minimum of 6+ years of progressive financial reporting and/or corporate financial planning and analysis experience
• Strong proficiency in Excel and PowerPoint required, experience with BPC or other financial consolidations system strongly preferred
• Strong understanding of systems, analytical tools, financial modeling, and data management
• Able to juggle multiple priorities without sacrificing quality and timeliness
• Hands-on approach with a focus on continuous improvement
• High-energy self-starter with history of successful accomplishments
• Polished communication, presentation and interpersonal skills
• Solid team player with demonstrated ability to drive cohesion and collaboration

Position Description:

 The R&D Finance Business Partner will be an integral member of Ironwood’s financial planning team imbedded within the company’s R&D organization. The successful candidate will partner with multiple business leaders across R&D to assess functional needs and proactively leverage subject matter expertise to analyze, identify and share opportunities for improved financial performance and strategic decision making. 

Responsibilities:

• Design, develop, and implement financial tools and metrics to support the R&D team and provide direction in decision making that helps effectively allocate resources in support of the company's strategic goals.
• Lead / facilitate R&D financial performance review process including: distribution of monthly performance reports, hands-on management of consolidated R&D review materials, and facilitation of R&D leadership review meetings.
• Manage monthly process for analyzing complex R&D long-term contracts which require significant judgment including those for clinical trials, contracted research, and validation and pre-validation activities with contract manufacturing organizations
• Lead all R&D financial processes to ensure integration and alignment with corporate wide business & financial planning processes.
• Facilitate / develop long range financials supporting the strategic planning process.
• Lead/support continuous improvement initiatives and sharing of best practices across finance and the broader organization.
• Perform ad hoc analysis on various business aspects as required.

Requirements:

• Bachelors or equivalent degree required; concentration in a financial discipline and/or MBA preferred;
• 8+ years of progressive financial reporting , planning and analysis experience  in the pharmaceutical, biotechnology or health care industry;
• Prior experience supporting R&D organizations/teams;
• Strong facilitation, communication and presentation skills; must have a sincere willingness and demonstrated ability to work collaboratively and partner successfully with non-Finance personnel while remaining a strong representative of/for the Finance team;
• 5+ years of experience working in a matrix environment – including successful interaction with leadership of multiple functions and programs. Ability to influence at all organizational levels within cultural expectations;
• Strong proficiency in Excel and PowerPoint required, experience with BPC or other financial consolidations system strongly preferred;
• Strong understanding of systems, analytical tools, financial modeling, and data management;
• Strong understanding of GAAP and financial statement reporting preferred.

Position description:

The Senior Manager, Commercial Finance will have an opportunity to be the finance business partner for the Commercial organization in a dynamic integrated pharmaceutical company.  They will partner with multiple business leaders across the Commercial organization to assess functional needs and proactively leverage subject matter expertise to analyze, identify and share opportunities for improved financial performance and strategic decision-making. 

Responsibilities:

• Design, develop, and implement financial tools and metrics to support the Commercial team and provide direction in decision making that  helps effectively allocate resources in support of the Company’s strategic goals
• Lead Commercial financial performance review processes, including: analysis of monthly financial performance and operating expenses, Rx demand analytics and metrics, detailed reviews of net sales, and salesforce metrics and budget management
• Actively collaborate with the Company’s co-promotion and collaboration partnerships to execute on shared brand strategy and brand-specific financial goals
• Lead and manage all phases of the quarterly forecasts and annual operating plan
• Prepare financial models for the long-range plan process and ad hoc commercial-related analyses for business development
• Evaluate business opportunities through financial modeling and  valuations
• Assist the commercial leadership team in the preparation of Board of Directors’ meeting materials, quarterly prescription and commercial financial analytics
• Identify and create custom reports based on business needs utilizing the Company’s financial planning and consolidation ERP system (SAP and BPC)
• Review commercial accrued expenses
• Manage one direct report 

Requirements:

• A minimum of 7+ years of experience in financial planning, business analytics, accounting in the biotech/ pharmaceutical industry
• Excellent financial modeling, communication and presentation skills required
• Strong understanding of US GAAP and financial statement reporting in the biotech/pharma industry required
• Specific experience utilizing ERP and consolidation systems including SAP and BPC preferred
• Demonstrated ability to influence and build strong working relationships with business partners; exceptional follow-through skills
• Ability to think strategically while also comfortable with details;
• Advanced skills with Microsoft Office (Excel and PowerPoint) required

Education

• Bachelors or equivalent degree required; concentration in a financial discipline preferred
• MBA or CPA strongly preferred

OBJECTIVES:

• The Quality Engineer will liaise with technical groups in the development of drug delivery devices. Scope includes a wide range of devices, such as: needle protection systems, fluid transfer devices, pen injectors and automatic pen injectors.
• The qualified candidate will work with technical teams to ensure successful device development of these mechanical devices. The Quality engineer will work closely with team members to develop compliant detailed engineering specifications, device design and development, support verification, validation and regulatory submissions of the combination devices.
• The role of the Quality engineer is to work within a cross functional organization to lead Quality oversight, ensure compliance, utilize technologies and methodologies that support short-cycle robust device development.

ACCOUNTABILITIES:

• Work cross functionally with individuals and project teams in Marketing, Operations and Technical Development.
• Support CMO site selection, product transfers and device/combination product commercialization
• Support new technology evaluation and development products produced at CMO’s.
• Mange the process for the creation and assessment of product requirements to determine technical coverage and proper integration of different subsystems.
• Identify deliverables and establish documentation required for project support in accordance with applicable SOP’s, standard and design controls.
• Author and/or review, execute and approve requirement documents, design documents, specifications, development plans, characterization plans, verification and validation plans (including human factor studies) and test protocols, reports and other related product development documents for assigned products.
• Review and approve process validation reports from CMO’s to assure they meet regulatory requirements and support regulatory filings.
• Provide oversight of design verification and validation performed by CMO’s and assure design or the device and packaging are verified.
• Troubleshoot and direct the resolution of complex quality issues during design and development and during technical transfer.
• Train employees in design controls, risk management, inspection, statistical and problem techniques.
• Participate in the resolution of complaints.
• Perform 1st piece and 1st article inspection.
• Develop/maintain quality risk management plans; utilize risk management tools to identify and mitigate CMO quality and compliance risks, ensuring CMO sites are in a state of continuous inspection readiness.
• Conduct FMEA’s, assist in the development of process capability studies and DOE’s.
• Develop and maintain trace matrices during the development process.
• Create and update any quality systems documents related to combination products development

Qualifications 

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• This position requires at a minimum a bachelor’s degree, preferably in a technical field relating to engineering or science
• 5 – 7years experience with engineering processes and procedures in the medical device industry dealing with product development.
• Product design/development (design controls) experience from concept to post launch for Europe & US submissions.
• Experienced in protocol and report writing, process and test development, prototyping, design verification. DOE/SPC process optimization and validation (IQ, OQ, PQ) and risk management activities.
• Good communication skills, team player and ability to multi-task.
• Promotes process improvement
• Proficient in Microsoft Office, Visio and electronic trace matrix software.
• Knowledge of quality and statistical analysis is required.

TRAVEL REQUIREMENTS: 

• Travel 15-25%

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY):

• Three – five years device product development engineering
• CAD experience
• Tolerance stack-up experience

we are driven to improve people's lives

www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx  

 No Phone Calls or Recruiters Please.

Our Client, a CLIA-certified genetic testing company, is looking for an Associate Lab Director.

In this role, you will review clinical data and reports, participate in development of new tests, and develop enhanced quality metrics.

Requirements

•  Ph.D. from an accredited institution with a chemical, physical or biological science at your major subject.
• Board Certified by the American Board of Medical Genetics or Active Candidate Status. I
• Certified by the NY State Department of Health in Genetic Testing preferred.
• You must also have a broad knowledge of CLIA, NY CLEP regulations and CAP accreditation requirements.
• Ability to mentor staff and vendors.
• A deep knowledge of genetics, preferably in next generation sequencing

Our client is seeking a motivated and experienced individual with expertise in cell and molecular biology to join our R&D Cell Line Development and Expression group.  The successful candidate will play an integral role as a key team member of a group focused on the development, expression and characterization of high productivity mammalian CHO cell lines for the production of monoclonal antibodies, recombinant proteins, and novel molecules.

Job Responsibilities:

Responsibilities will include aseptic culture of mammalian cells, transfection and selection of CHO cells, single cell cloning, together with the evaluation of cell lines in scale-down models of production processes. Activities also include the expression of these cell lines up to the 250L scale.  The successful candidate will work closely with other team members and contribute to experimental designs and interpretation.

Basic Qualifications:

The successful candidate should have a B.S. or M.S. in biological sciences or related life science discipline, together with 5-7 years of relevant industrial experience. The qualified candidate will have:

• Deep knowledge of cell biology and cell culture of mammalian cells.  Hands-on expertise in laboratory cell culture operations such as wave bioreactors, shake flasks, spin-tube, and plate-based culture formats.
• Previous experience in the development of high productivity mammalian production lines is required.
• Experience designing and executing cell line development, clone screening, and clone selection for recombinant cell lines to support clinical and commercial manufacturing of new therapeutics entering clinical development.
• The ability to develop and optimize new protein expression platforms by evaluating various gene constructs and expression systems.
• Experience in writing of technical reports in support of patent applications, IND filings and scientific publications.
• Working knowledge of the techniques used for the analysis of protein expression (ELISA, Western Blot, Octet).
• The ability to drive innovation and solve technical problems while working independently and in cross-functional teams.
• Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment are essential.

Temporary Assignment for 2+ months (40 hours per week) 

Our client, a well recognized Hospital, seeks a Molecular Biology Technologist to work in their CLIA lab

Responsibilities:

• This individual will be responsible for helping in validation of newly developed Next Generation sequencing assays in preparation for CLIA laboratory processing and will perform all testing consistent with established procedures and quality standards.
• The Molecular Laboratory Technologist will interface directly with the Laboratory Director, Technical Supervisor, General Supervisor, and other Testing Personnel to drive the utmost quality and throughput of diagnostics offering.

Requirements:

• BS/MS w/ 1+ years of experience working in a Molecular Biology Lab, preferably Clinical Lab.
• Next-Gen Sequencing highly desired
• General Molecular Biology background is a Must

Job Title: Senior Clinical Trial Manager

The Senior Clinical Trial Manager will lead the forecasting, planning and manage the implementation of the clinical operational plans in alignment with the company’s strategic objectives, and in accordance with regulatory guidelines and Good Clinical Practice. Reporting to the Senior Director of Clinical Operations, the individual will be responsible for effective global management of relationships and establishes strong partnerships with external team/vendors activities including investigators, CROs, central labs, and other external partners.

Job Requirements:

• Bachelor’s degree in life sciences or equivalent training required
• At least 7 years of experience in clinical trials management preferably in Phase 2 – 3
• 3+ years as a Clinical Trial/Project Manager in the oncology therapeutic area required
• Oncology experience Required
• Must have solid experience with global studies in a CRO or bio-pharma setting
• Must have solid experience managing CRO vendors
• Prefer people that can lead  clinical staff including study managers, CRAs, monitors and coordinators
• Must be willing to travel, both domestic and international

Associate Scientist/Scientist Protein Engineering

PhD Scientist needed for bacterial protein expression, protein purification, protein characterization, and some experimental design. Techniques include: FPLC, His-tag, protein conjugation, and flow cytometry. Strong level of independence working in a fast-paced environment within a team environment. Position is a full-time (40 hr/week) contract role and located in Cambridge.

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Senior Research Associate

Position Summary

We are seeking an Associate to join our Research Department in Cambridge, MA.  The ideal candidate is a motivated, energetic, detail-oriented person who will design and carry out experiments with limited supervision.  Position involves making contributions to experimental design and data analysis.  Must have the capacity to adapt, and demonstrate a strong desire to learn new concepts and techniques.  Expected to work well within a dynamic and team-oriented small company environment.

Primary Responsibilities

• Immunological-based techniques including ELISA-based assays, and functional T cell assays (e.g., antigen presentation, ELISPOT, Luminex, multicolor flow-cytometry).
• Animal modeling of infection and vaccination.
• Cell culture and molecular biology techniques (qPCR, western blots, etc).
• Independently design experiments, analyze data and prepare reports.
• Maintain basic knowledge of principals in field(s) at hand.
• Prepare slide decks independently and present them for internal company meetings.
• Maintain literature files and accurate laboratory records and notebooks.
• Troubleshoot experimental process under minimal supervision.

Required Skills

• A solid theoretical understanding of and experience with cellular and molecular immunology techniques. Assay development experience is a plus.
• Proficiency with in vivo mouse models of infection or disease.
• Ability to analyze data, draw conclusions, communicate results and compile technical reports.
• Excellent record keeping abilities to adequately record and document analytical data.
• Solid technical knowledge and hands-on experience.
• Ability to work effectively in a cross-functional setting.
• Capacity to adapt, with a strong desire to learn new concepts and techniques.
• Excellent communication, problem solving and analytical skills. Strong organization and ability to multi-task.

Education & Experience

Master’s degree with a minimum of 3 years or Bachelor’s degree with a minimum of 5 years of experience in biopharmaceutical industry

To apply for this position, please CLICK HERE

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Bioassay Scientist

Position Summary

Seeking a top notch contributor to join our dynamic and dedicated team. The Bioassay Scientist will be expected to plan and execute experiments as well as analyze data generated by other internal and external contributors. The candidate will have demonstrated hands-on experience with in vivo and cell-based potency assays, technology transfer, data analysis and troubleshooting. The successful candidate will supervise a small team that supports the evaluation of immunogenicity and efficacy of candidate vaccine formulations both in mouse models and in vitro. He/she will work closely with our Biopharmaceutical Development and Production group to support our vaccine development programs with reliability, integrity, and commitment while working in a cross-functional setting.

Competencies and Responsibilities

•  Provide technical resource for bioassay method development, optimization, implementation and validation.
• Assist with feasibility studies and method transfers within and outside of Genocea.
• Routine review of method performance, design and execution of remediation experiments should discrepancies be identified, and development and implementation of improvements to existing assay methods.
• Assist in maintaining critical reagent supply and instrumentation for assigned methods.
• Write animal use protocols, SOPs, validation protocols, and study reports.
• Work collaboratively across organization and sites for method readiness, transfer, performance and troubleshooting.
• Work closely with Biopharmaceutical Development and Production, Vaccine Development, and Translational Medicine team members to understand their deliverables to achieve organization goals.
• Ability to work independently and as a part of a cross-functional team with a positive attitude.
• Performance of in vivo and in vitro bioassays for vaccine development, comparability, potency, and lot release studies.
• Demonstrated experience with bioassay method development, qualification and validation is necessary.
• Experience with vaccine potency assays is a plus.

Education and Experience Requirements

•  PhD with a minimum of 4 years of relevant experience with bioassays and immunoassays in biologics process development.
• Relevant experience in industry is a must.

To apply for this position, please CLICK HERE

Position Summary
Moderna is seeking a Senior Scientist for a position based at their Cambridge, MA site, reporting to the head of Personalized Cancer Vaccines (PCV). The individual in this role will lead the preclinical research team charged with building a world class PCV platform. In close collaboration with the PCV Head and Bioinformatics Leader he/she will take a hands on approach to establishing in vitro and in vivo model systems that will drive the short and long-term goals of delivering personalized vaccines to patients suffering from cancer. The selected individual will work with scientists, regulatory experts, manufacturing specialists, external partners and the larger Moderna community to create this first and best in class platform.

Responsibilities
* Design, perform and interpret results from experiments focused on achieving the goals of the PCV.
* Contribute to the PCV strategy by addressing key Go/No-Go decisions experimentally
* Identify, deploy, and maintain oversight of the required internal and external resources, i.e. partners and collaborators;
* Work with the larger cross-functional matrix teams to realize the clinical success of the PCV, including analytical, operational, and regulatory aspects.
* Identify and validate innovative approaches to improve quality and efficiency of immunological research.
* Maintain current awareness of emerging concepts, approaches, and methods in immunobiology and provide ad-hoc support to cross-disciplinary project teams.

Minimum Qualifications
* PhD, MD or equivalent in Biological Sciences with a proven track record in human immunology research
* 5 years post-doctoral research with emphasis on antigen processing/presentation and HLA diversity
* Experience with vaccines, immuno-oncology and/or bioinformatics desirable.
* In depth knowledge of assays and model systems to study immunology both in vivo and in vitro
* Demonstrated ability for sound experimental design with the talent and work ethic to develop innovative model systems to meet the emerging challenges of the PCV
* In depth knowledge of immunological literature and the ability to apply new and old concepts to the questions at hand
* Commitment to performing technically complex experiments while managing research team and interacting regularly with stakeholders
* Exceptional communication skills (oral and written) as demonstrated by publications & presentations.

Preferred Qualifications
* Demonstrable organizational skills, including knowledge of drug development
* Strong work ethic and a team orientation
* Attention to detail and a passion for winning
* Highly effective oral and written communication skills
* Technical expertise in biochemistry/cell biology and scientific rigor

Competencies:
* Effective Communication
* Flexibility/Adaptability to Change
* Contributing to Team Success
* Planning and Organizing
* Technical/Professional Knowledge

Why Join Moderna
Moderna is pioneering messenger RNA Therapeutics -, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci42NDUxOC4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t

Position Summary
Moderna is seeking a highly skilled and motivated immunologist ready to function in a fast-paced and collaborative environment for a position based at their Cambridge, MA site. Applicants will help to develop the in vitro immunology data package to support advancement of Moderna's mRNA technology platform. The individual in this role will investigate molecular and cellular mechanisms in the immune response and will also be responsible of the lab maintenance.

Responsibilities
* Development and performance of in vitro/ex vivo assays (Flow cytometry, ELISA, ELIspot, and related)
* Standard cell culture support including maintaining and plating of cell lines, primary cells...
* General laboratory assistance including lab equipment maintenance and the ordering and receiving of lab supplies
* Accountable for project success and results delivery
* Closely collaborate with other members within the group
* Record and communicate findings

Minimum Qualifications
* BS with at least 5 years of industry experience or MS with 3 years of industry experience performing in vitro screening performing in vitro/ ex vivo immunology experiments
* Required high knowledge of and experience in immunology including Flow cytometry, ELISA, ELIspot, luminescent and fluorescent based assay development
* Hands on experience with cell culture (cell lines and primary cell culture)
* Excellent skills and ability to work efficiently and productively and a highly dynamic environment

Preferred Qualifications
* Experience in flow cytometry
* Experience with characterization of cellular immune response
* Background in immunology

Competencies
* Effective Communication
* Flexibility/Adaptability to Change
* Continuous Learning
* Contributing to Team Success
* Energy
* Planning and Organizing

Why Join Moderna
Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci45MjU1Ni4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t

Primary Duties :
Primary objective of Manager, Business Operations GHEORE (Global Health Economics Outcomes Research and Epidemiology) is to minimize non-scientific demands on our technical staff. The successful candidate will have broad responsibilities including by not limited to preparing contracts, processing & tracking Purchase Orders (POs), Statements of Work (SOWs), and Service Agreements for the GHEOR and epidemiology teams. Works with internal IT to execute against site and process improvements for the applicable systems. Work with the VP of GHEORE to enhance process efficiencies

Responsibilities:
The responsibilities of the successful candidate are expected to evolve with the needs of the department and his/her professional development goals. Current responsibilities will include:

20%: Decision Support
* Identify and execute against opportunities for improvement of related to GHEORE tracking systems, reporting and other processes.

60%: Support Business Processes
* Serve as member of the GHEORE Leadership Team.
- Provide operational perspective to discussions.
- Capture and distribute minutes of GHEORE Leadership meetings.
* Liaise with GHEORE stakeholders, Procurement, and Legal to facilitate efficient internal vendor-associated communication and external vendor management and training.
* Support procure-to-pay process through coordination of contracts, purchase orders, and invoices.
* Support quarterly tax credit exercise: release time allocation surveys, compile and consolidate results, develop review materials and final submission.
* Obtain and prepare vendor information and proposals for submission to Legal Department for creation of Service Agreements. Set up new vendors when necessary and monitor the database for problems after vendors complete the registration. Ensures that confidentiality agreements and other key contractual elements are in place
* Maintain understanding of new Procurement/AP/Legal/Finance requirements for vendor and budget management
* Complete the RND Select process as needed

20%: Communication
* Generate slides for various needs of GHEORE leadership
* Maintain GHEORE Projects SharePoint and manage site access requests,
- Support compilation of monthly reports
- Work with internal IT SharePoint team to execute against site and process improvements.
* New Hire Profiles: Collect profiles from hiring managers, draft communications periodically (quarterly, at minimum)
* Manage GHEORE departmental Gopher site

Education and Experience Requirements :
Bachelor's degree in scientific discipline, or business administration with an understanding of R&D, plus minimum of 5 years of professional experience. Preferred qualifications include experience in biotech/pharmaceutical industry

Other Job Requirements:
Occasional domestic may be required

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjM5NDAyLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Clinical Project Manager

Location: Lexington, MA

Job Description

Promedior has advanced its lead program (PRM-151) into clinical trials focused on two orphan fibrotic diseases, myelofibrosis and idiopathic pulmonary fibrosis. As we enter this critical period in the clinical development cycle we will need a Clinical Project Manager to provide strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of the projects, the ability to zoom in and out as the situation demands. The Clinical Project Manager should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand implications of decisions that affect study outcomes and timelines.

Role Purpose:

• Leads  several clinical studies  under a  distinct program  and is seen as the standard  for project management at Promedior by demonstrating a high level of knowledge  of clinical operations’ methodologies, organizational, project management and  leadership capabilities as well as increased strategic insight, decisiveness  and strong judgment
• Works  to ensure that the standardized approach to project management established by  Clinical Operations is adhered to
• Manages  clinical trials projects through leadership of and delegation to a cross-functional  study execution team, working under the guidance and direction of a Program  Lead. May be required from time to time to serve as a coach and mentor to  Clinical Trial Managers and junior staff
• Ensures  successful clinical trial planning, execution and delivery – within specified  quality, time and cost parameters
• As  a result of a strong understanding of methodologies and approaches, ensures  alignment of clinical project goals with Clinical Operations program objectives

Role Accountabilities

• Develops  a quality control plan for trial master files and then ensures those TMFs are  created, maintained, monitored, and closed out on a timely basis
• Actively  participates in the development of department initiatives, including acting as  lead on the development/definition of certain SOPs and processes; makes  recommendations on how best to approach, manage and engage others on department  initiatives
• Ensures  that an overarching trial cross-functional quality plan is in place and adhered  to
• Oversees  and manages vendors (CRO) to ensure that Promedior's clinical trials are  getting the necessary resources and attention the vendor has committed to  ensure trial deliverables and performance goals are met. 
• Develops  project management skills in self and others to increase consistency and drive  Clinical Operations performance; mentors CPM, and CTM staff as appropriate
• Manages  ancillary vendors, including IVRS, central lab imaging vendor, central ECG,  central pathology selection, set-up, conduct, and close-out
• Oversees  the development of and adherence to clinical trial project timelines and  ensures senior Clinical Development staff informed of and understand risks /  challenges, which includes putting risk mitigation plans in place, monitoring  risk metrics, and communicating those risks
• Ensures  that all clinical data, including third party data, is managed and completed in  a timely manner in order to enable Data Management to lock the database on  appointed dates
• Ensures  that external partnerships (e.g. CRO) are effectively supporting clinical  trials, within contracted terms including budget;
• Adheres  to clinical trial budgeting process and provides input on process optimization
• Leads  matrix, multi-disciplinary, cross-functional study execution teams from  start-up through close to ensure both internal and external deliverables are on  time and on budget
• Has  both an internal and external perspective on clinical trial management; ensures  that clinical trials are operationally feasible while understanding the  external landscape, including a focus on KOL activity and the competitive  landscape
• Proactively  identifies, negotiates and brokers solutions to individual clinical study  issues
• Delegates  and oversees the management of certain aspects of project management to CTM  staff to ensure clinical studies at a project level are executed within  specified time, quality and cost parameters

Skills and Experience

• Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 10 years of experience in clinical research operations.
• Experience in running one or more clinical studies in the following therapy areas is desirable: rare disease, fibrotic disease (Idiooathis Pulmonary Fibrosis, Myelofibrosis, Retinal Fibrotic Disease) and/or oncology.
• Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
• Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
• Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
• Demonstrated experience in study management/monitoring and data management, working with, and negotiating with Clinical Research Organizations (CROs).
• Demonstrated project management expertise, including the leadership and development of cross functional teams.
• Demonstrated ability to work independently with exceptional organization and attention to detail.
• Excellent oral and written communication and presentation skills.

Interested candidates may apply by sending a CV/resume and a cover letter to  jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age related macular degeneration, diabetic nephropathy, nonalcoholic steatohepatitis (NASH), and several types of solid tumors. 

Clinical Project Manager

Location: Lexington, MA

Job Description

Promedior has advanced its lead program (PRM-151) into clinical trials focused on two orphan fibrotic diseases, myelofibrosis and idiopathic pulmonary fibrosis. As we enter this critical period in the clinical development cycle we will need a Clinical Project Manager to provide strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams. They should have the command of the projects, the ability to zoom in and out as the situation demands. The Clinical Project Manager should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study(ies) and understand implications of decisions that affect study outcomes and timelines.

Role Purpose:

• Leads  several clinical studies  under a  distinct program  and is seen as the standard  for project management at Promedior by demonstrating a high level of knowledge  of clinical operations’ methodologies, organizational, project management and  leadership capabilities as well as increased strategic insight, decisiveness  and strong judgment
• Works  to ensure that the standardized approach to project management established by  Clinical Operations is adhered to
• Manages  clinical trials projects through leadership of and delegation to a cross-functional  study execution team, working under the guidance and direction of a Program  Lead. May be required from time to time to serve as a coach and mentor to  Clinical Trial Managers and junior staff
• Ensures  successful clinical trial planning, execution and delivery – within specified  quality, time and cost parameters
• As  a result of a strong understanding of methodologies and approaches, ensures  alignment of clinical project goals with Clinical Operations program objectives

Role Accountabilities

• Develops  a quality control plan for trial master files and then ensures those TMFs are  created, maintained, monitored, and closed out on a timely basis
• Actively  participates in the development of department initiatives, including acting as  lead on the development/definition of certain SOPs and processes; makes  recommendations on how best to approach, manage and engage others on department  initiatives
• Ensures  that an overarching trial cross-functional quality plan is in place and adhered  to
• Oversees  and manages vendors (CRO) to ensure that Promedior's clinical trials are  getting the necessary resources and attention the vendor has committed to  ensure trial deliverables and performance goals are met. 
• Develops  project management skills in self and others to increase consistency and drive  Clinical Operations performance; mentors CPM, and CTM staff as appropriate
• Manages  ancillary vendors, including IVRS, central lab imaging vendor, central ECG,  central pathology selection, set-up, conduct, and close-out
• Oversees  the development of and adherence to clinical trial project timelines and  ensures senior Clinical Development staff informed of and understand risks /  challenges, which includes putting risk mitigation plans in place, monitoring  risk metrics, and communicating those risks
• Ensures  that all clinical data, including third party data, is managed and completed in  a timely manner in order to enable Data Management to lock the database on  appointed dates
• Ensures  that external partnerships (e.g. CRO) are effectively supporting clinical  trials, within contracted terms including budget;
• Adheres  to clinical trial budgeting process and provides input on process optimization
• Leads  matrix, multi-disciplinary, cross-functional study execution teams from  start-up through close to ensure both internal and external deliverables are on  time and on budget
• Has  both an internal and external perspective on clinical trial management; ensures  that clinical trials are operationally feasible while understanding the  external landscape, including a focus on KOL activity and the competitive  landscape
• Proactively  identifies, negotiates and brokers solutions to individual clinical study  issues
• Delegates  and oversees the management of certain aspects of project management to CTM  staff to ensure clinical studies at a project level are executed within  specified time, quality and cost parameters

Skills and Experience

• Requires a BA/BS preferably in nursing, biology, biochemistry, or related areas (advanced degrees desirable) with at least 10 years of experience in clinical research operations.
• Experience in running one or more clinical studies in the following therapy areas is desirable: rare disease, fibrotic disease (Idiooathis Pulmonary Fibrosis, Myelofibrosis, Retinal Fibrotic Disease) and/or oncology.
• Ensures adherence to standard operating procedures, good clinical practice, and FDA regulations with strong understanding of inspection readiness.
• Fluent in Good Clinical Practice (GCP) and is able insure implementation within any clinical study.
• Demonstrated knowledge and experience in the regulatory aspects of pharmaceutical development, including protocol implementation, data collection and reporting, and understands preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA) specifically for FDA and EMA.
• Demonstrated experience in study management/monitoring and data management, working with, and negotiating with Clinical Research Organizations (CROs).
• Demonstrated project management expertise, including the leadership and development of cross functional teams.
• Demonstrated ability to work independently with exceptional organization and attention to detail.
• Excellent oral and written communication and presentation skills.

Interested candidates may apply by sending a CV/resume and a cover letter to  jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age related macular degeneration, diabetic nephropathy, nonalcoholic steatohepatitis (NASH), and several types of solid tumors. 

Director, Clinical Development Operations

Location: Lexington, MA

Job Description

Promedior has advanced its lead program (PRM-151) into clinical trials focused on two orphan fibrotic diseases, myelofibrosis and idiopathic pulmonary fibrosis. As we enter this critical period in the clinical development cycle we are seeking a Director Clinical Development Operations to be a key leader in helping to design, implement and manage the ongoing success of Promedior’s full-service CRO outsourcing strategy. This individual will provide leadership to move the organization to a true vendor oversight model based on mutual trust, reliable and consistent quality, timeliness of delivery, and value-driven results. The individual will collaborate across functions and organizations to ensure both clearly defined accountability within Promedior and successful transfer of appropriate accountability to Vendors. This individual will be a key resource across the organization at all levels -- for securing and maintaining alignment in direction and delivery of Promedior’s outsourced activities. Additionally, this individual will design, implement and manage the program timeline and budget in collaboration with Promedior colleagues involved in trial conduct activities.

Responsibilities

Operating principles of the outsourcing strategy

• In collaboration with Development peers, design, document and implement outsourcing operating principles to achieve and maintain quality, timeliness and robust cost management
• Ensure consistent understanding and application of these operating principles and practices across both Promedior and our CRO partners(s) through communication, training, leadership and mentoring
• Manage across all levels of the organization to help obtain buy-in and promote the success of the outsourcing strategy
• Create and implement an onboarding methodology to orient new team members to the outsourcing strategy
• Engage stakeholders in ongoing open dialogue that uncovers challenges and leads to a strengthening of the outsourcing model
• Ensure that robust trending of operational issues and opportunities, risk mitigation planning and proactive management of unforeseen challenges is fully implemented
• Act as a positive role model for the partnership mentality across the organization

Relationship Management and Governance

• Act as the primary counterpart within Promedior for the CRO Relationship Manager to achieve partnership strategic commitments
• Liaise frequently with Promedior colleagues and CRO counterparts to maintain a full understanding of potential issues and concerns and ensure they are appropriately acknowledged, addressed and resolved in a timely fashion
• Ensure that an atmosphere of trust, openness and mutual respect is established
• Develop a mechanism for celebrating Promedior and CRO(s) mutual successes as well as helping teams manage through challenges
• Ensure appropriate measures of success based on quality, timeliness and cost management are established, reported and acted on
• Establish appropriate forums, both internal and collaborative with the CRO(s) for the exchange of ideas, best practices, process improvements and risk mitigation, as well as a mechanism for the approval, implementation and evaluating the success of those outputs
• Create a robust formal governance structure with the CRO(s) that includes, for each relationship as appropriate, an Executive Steering Committee, a Joint Operations Committee, a Business Operations Committee and a Committee to govern process improvement initiatives
• Ensure formal governance meetings are scheduled, conducted and appropriately documented, and that outputs are communicated broadly throughout relevant areas of both Promedior and CRO(s)
• Design and implement an effective issue escalation pathway. Provide regular training, communication about actions taken and report on results on a timely basis. Provide stakeholders with relevant tools and processes to ensure most issues can be successfully addressed at the program team level.
• Develop a methodology for documenting and reinvesting the contributions of continuous improvement

Program Timeline and Budget Management

• In collaboration with Development peers, develop, implement and manage program timeline and budget.
• Establish appropriate forums to review budget, as well as a mechanism for handling budget variances and approvals.
• Responsible for multiple aspects of clinical trial budgets. This includes creating processes around the oversight and management of budgets, providing guidance on decision making related to clinical trial budgets, assisting with budget reconciliation and invoice management activities, and ensuring that Clinical Operations project managers are maintaining budgets within corporate guidelines.
• Responsible for high-level and detailed study budget forecasting for all program/portfolios, including setting baseline budget for RFP processes
• Responsible for budget analyses and recommendations in support of strategic program decision-making
• Houses, tracks and interprets clinical study assumptions, serving as a central source of information
• Manage budgetary requirements of clinical program, by providing consolidated latest estimates on current year budget and future year planning budget. Identify issues and propose mitigating plans for facilitating decision making.
• Track program/trial timelines, resource requirements and expenditures and initiate discussions on variances and adjustments as needed.
• Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning.
• Develop, track and report on program timeline, budget and quality metrics.

Requirements

• Demonstrates extensive clinical trials / program management experience, preferably 10+ years. 
• Experience in overseeing strategy on multiple international clinical studies in the following therapy areas is desirable: rare disease, fibrotic disease (Idiooathis Pulmonary Fibrosis, Myelofibrosis, Retinal Fibrotic Disease) and/or oncology.

• Demonstrates excellence in complex project management and effective management of multiple projects/priorities and budgets.
• Demonstrates understanding of pharmaceutical regulatory requirements and strategic implications for clinical development operations.
• Demonstrates ability to lead multifunctional teams, and mentor and coach more junior staff.
• Extensive experience of managing / overseeing CROs /vendors / external partnerships and relations. 
• Excellent verbal, written and presentation skills

Interested candidates may apply by sending a CV/resume and a cover letter to  jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age related macular degeneration, diabetic nephropathy, nonalcoholic steatohepatitis (NASH), and several types of solid tumors. 

Director, Clinical Development Operations

Location: Lexington, MA

Job Description

Promedior has advanced its lead program (PRM-151) into clinical trials focused on two orphan fibrotic diseases, myelofibrosis and idiopathic pulmonary fibrosis. As we enter this critical period in the clinical development cycle we are seeking a Director Clinical Development Operations to be a key leader in helping to design, implement and manage the ongoing success of Promedior’s full-service CRO outsourcing strategy. This individual will provide leadership to move the organization to a true vendor oversight model based on mutual trust, reliable and consistent quality, timeliness of delivery, and value-driven results. The individual will collaborate across functions and organizations to ensure both clearly defined accountability within Promedior and successful transfer of appropriate accountability to Vendors. This individual will be a key resource across the organization at all levels -- for securing and maintaining alignment in direction and delivery of Promedior’s outsourced activities. Additionally, this individual will design, implement and manage the program timeline and budget in collaboration with Promedior colleagues involved in trial conduct activities.

Responsibilities

Operating principles of the outsourcing strategy

• In collaboration with Development peers, design, document and implement outsourcing operating principles to achieve and maintain quality, timeliness and robust cost management
• Ensure consistent understanding and application of these operating principles and practices across both Promedior and our CRO partners(s) through communication, training, leadership and mentoring
• Manage across all levels of the organization to help obtain buy-in and promote the success of the outsourcing strategy
• Create and implement an onboarding methodology to orient new team members to the outsourcing strategy
• Engage stakeholders in ongoing open dialogue that uncovers challenges and leads to a strengthening of the outsourcing model
• Ensure that robust trending of operational issues and opportunities, risk mitigation planning and proactive management of unforeseen challenges is fully implemented
• Act as a positive role model for the partnership mentality across the organization

Relationship Management and Governance

• Act as the primary counterpart within Promedior for the CRO Relationship Manager to achieve partnership strategic commitments
• Liaise frequently with Promedior colleagues and CRO counterparts to maintain a full understanding of potential issues and concerns and ensure they are appropriately acknowledged, addressed and resolved in a timely fashion
• Ensure that an atmosphere of trust, openness and mutual respect is established
• Develop a mechanism for celebrating Promedior and CRO(s) mutual successes as well as helping teams manage through challenges
• Ensure appropriate measures of success based on quality, timeliness and cost management are established, reported and acted on
• Establish appropriate forums, both internal and collaborative with the CRO(s) for the exchange of ideas, best practices, process improvements and risk mitigation, as well as a mechanism for the approval, implementation and evaluating the success of those outputs
• Create a robust formal governance structure with the CRO(s) that includes, for each relationship as appropriate, an Executive Steering Committee, a Joint Operations Committee, a Business Operations Committee and a Committee to govern process improvement initiatives
• Ensure formal governance meetings are scheduled, conducted and appropriately documented, and that outputs are communicated broadly throughout relevant areas of both Promedior and CRO(s)
• Design and implement an effective issue escalation pathway. Provide regular training, communication about actions taken and report on results on a timely basis. Provide stakeholders with relevant tools and processes to ensure most issues can be successfully addressed at the program team level.
• Develop a methodology for documenting and reinvesting the contributions of continuous improvement

Program Timeline and Budget Management

• In collaboration with Development peers, develop, implement and manage program timeline and budget.
• Establish appropriate forums to review budget, as well as a mechanism for handling budget variances and approvals.
• Responsible for multiple aspects of clinical trial budgets. This includes creating processes around the oversight and management of budgets, providing guidance on decision making related to clinical trial budgets, assisting with budget reconciliation and invoice management activities, and ensuring that Clinical Operations project managers are maintaining budgets within corporate guidelines.
• Responsible for high-level and detailed study budget forecasting for all program/portfolios, including setting baseline budget for RFP processes
• Responsible for budget analyses and recommendations in support of strategic program decision-making
• Houses, tracks and interprets clinical study assumptions, serving as a central source of information
• Manage budgetary requirements of clinical program, by providing consolidated latest estimates on current year budget and future year planning budget. Identify issues and propose mitigating plans for facilitating decision making.
• Track program/trial timelines, resource requirements and expenditures and initiate discussions on variances and adjustments as needed.
• Ensure clinical trial planning and budgeting systems are accurate regarding timelines, forecasts, expenditures and internal resource planning.
• Develop, track and report on program timeline, budget and quality metrics.

Requirements

• Demonstrates extensive clinical trials / program management experience, preferably 10+ years. 
• Experience in overseeing strategy on multiple international clinical studies in the following therapy areas is desirable: rare disease, fibrotic disease (Idiooathis Pulmonary Fibrosis, Myelofibrosis, Retinal Fibrotic Disease) and/or oncology.

• Demonstrates excellence in complex project management and effective management of multiple projects/priorities and budgets.
• Demonstrates understanding of pharmaceutical regulatory requirements and strategic implications for clinical development operations.
• Demonstrates ability to lead multifunctional teams, and mentor and coach more junior staff.
• Extensive experience of managing / overseeing CROs /vendors / external partnerships and relations. 
• Excellent verbal, written and presentation skills

Interested candidates may apply by sending a CV/resume and a cover letter to  jobs@promedior.com

Promedior is a clinical-stage immunotherapy company pioneering the development of targeted therapeutics to treat diseases involving fibrosis. Fibrosis occurs when healthy tissue is replaced with excessive scar tissue, compromising function and ultimately leading to organ failure. Fibrosis is a common feature of several rare diseases as well as more prevalent illnesses such as age related macular degeneration, diabetic nephropathy, nonalcoholic steatohepatitis (NASH), and several types of solid tumors. 

Are you an experienced and creative research associate with biotech/pharmaceutical experience that is seeking a role that will value your technical and mental contributions? Are you tired of being treated as the standard "pair of hands"? If so you need to take notice of our clients opportunity to add an experienced Principal Research Associate to their growing Biology team. They want a valuable contributor to help advance their pipeline studies that can think collaboratively and work with little hand holding.

Required and Desired Skills:

• Ability to think and contribute scientifically in group setting to add value to the organization
• Success in prioritizing work for targeting, identifying, and validation of oncology therapies
• Experience and expertise with oncology cell lines
• Hands on experience with ChIP Seq, genetic screening (siRNA, shRNA, CRISPRs), and novel and phenotypic assay development
• MS 5-10 years of industry experience. BS 10+ years of industry experience.

About StratAcuity

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Key Deliverables:

• Drive CMC regulatory submissions and identify possible regulatory challenges
• Proactively identify issues/problems and lead cross-team solutions
• Addresses complex issues and problems providing innovative solutions and guidance within the team and across the organization
• Act as liaison with internal and external teams outside of Regulatory Affairs to coordinate all activities needed for submissions
• Craft strategic changes to drive efficiencies and process improvements to support business objectives
• Prepares and delivers effective presentations for cross-functional internal audiences
• Represents Regulatory Affairs at internal and external meetings
• Mentors junior staff in area of expertise, may have supervisory responsibility

 About You:

•   Bachelor’s degree in a scientific discipline

•   4+ years of industry experience in pharmaceutical or biotech company

•   2+ years of experience working in regulatory affairs CMC

About StratAcuity

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™